The Comparative Study on the Efficacy and Safety of Single Acupoint and Matching Acupoints

The Different Effectiveness of Single Acupoint vs Matching Acupoints in Chemotherapy-induced Nausea and Vomiting：A Multicenter, Randomized, Controlled Clinical Trial

The purpose of this study is to clarify whether the matching acupoints are more effective than a single point by electro-acupuncture in the management of chemotherapy-induced nausea and vomiting.

Study Overview

• Status: Unknown
• Conditions: Chemotherapy-induced Nausea and Vomiting; Electro-acupuncture
• Intervention / Treatment: Other: Single points PC6; Other: Matching points PC6+CV12

• Study Type: Interventional
• Enrollment (Anticipated): 208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300193
      • Recruiting
      • Tianjin University of TCM
      • Contact: Guo Yi, Doc; Phone Number: 13920921016; Email: tjutcmacupuncture@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Be diagnosed as cancer and need to accept chemotherapy
2. The score of Karnofsky ≥70
3. Patients of either gender and age 18 years to 80 years
4. Patients receiving chemotherapy both outpatients and inpatients
5. Patients receiving chemotherapy regime with high risk of causing vomiting: cisplatin ≥60 mg/m2, or joint chemotherapy regime of Anthracyclines (Adriamycin≥ 40 mg/ m2 or epirubicin≥60 mg/m2), Dacarbazine or Carboplatin（area under the curve greater than 5mg/ml/min）
6. Life expectancy > 6 months

Exclusion Criteria:

1. To receive radiotherapy and chemotherapy
2. Gastrointestinal tumors
3. Patients with serious liver disease or abnormal hepatorenal function (Aspartate Aminotransferase, Alanine Aminotransferase , and Total Bilirubin are 3 times more than normal, blood urea nitrogen and Cr are 2 times more than normal)
4. Presence of cardiac pacemaker
5. Inflammatory skin reaction
6. Nausea and/or vomiting resulting from opioids or metabolic imbalance (electrolytic disturbances)
7. Patients unable to provide self-care or communication
8. Nausea and/or vomiting resulting from mechanical risk factors (i.e.,intestinal obstruction)
9. Patients with brain metastases or symptoms of intracranial hypertension
10. Nausea and/or vomiting resulting from other diseases(i.e.,sympathetic cervical dispositions, Meniere's syndrome)
11. Women in pregnant and lactating period
12. Refusal to sign informed consent, rejection of randomization into intervention groups.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electroacupuncture Single point; Single point PC6 means there is only one acupoint to be chosen: Neiguan(PC6)	Other: Single points PC6; Choose Neiguan(PC6)of double upper limb.The needles are connected through a electro-acupuncture apparatus, the positive poles are linked to the needle, and the reference poles are located near the acupoint about 1cm with a electrode.Frequency is 2/10 hertz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10 milliampere. And plus 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron，Granisetron or Ondansetron) and dexamethasone.
Experimental: Electroacupuncture Matching points; There are three acupoints to be chosen:Bilateral Neiguan(PC6)and Zhongwan(CV12)	Other: Matching points PC6+CV12; Choose both Neiguan(PC6) and Zhongwan point(CV12).The needles are connected through a electro-acupuncture apparatus, the positive poles are linked to the needle, and the reference poles are located near the acupoint about 1cm with a electrode.Frequency is 2/10 hertz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10 milliampere. And plus 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron，Granisetron or Ondansetron) and dexamethasone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Control rates of Nausea and Vomiting	There is no emetic episodes, no rescue therapy, and no significant nausea from first day of antiemetic therapy to 5th day.	6weeks
Complete Response rates of Vomiting	There is no emetic episodes and no rescue therapy on first day of antiemetic therapy and second day to 5th day.	6weeks
Nausea and Vomiting visual analogic scale (VAS)		6weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tcm Gastro-intestinal evaluation		3weeks
the grading of constipation ,diarrhea and decrease in appetite	Number of participants with constipation ,diarrhea and decrease events as assessed by CTCAE v4.0	3weeks
Electrogastrogram		3weeks
Hospital Anxiety and Depression Scale		3weeks
Functional Assessment of Cancer Treatment - General scale4.0		3weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Abnormal Laboratory Values	the number of blood cells,serumAlanine aminotransferase,Aspertate，Aminotransferase,total bilirubin,Creatinine，blood sodium，blood potassium	6weeks
cardial electrical activity		6weeks
other adverse effect during the chemotherapy		6weeks

Collaborators and Investigators

• Sponsor: Tianjin University of Traditional Chinese Medicine
• Collaborators: West China Hospital; Tianjin Medical University Cancer Institute and Hospital; Henan Provincial People's Hospital; National Basic Research Program, China; Gansu Provincial Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2017
• Primary Completion (Anticipated): April 28, 2018
• Study Completion (Anticipated): May 28, 2018

Study Registration Dates

• First Submitted: February 5, 2017
• First Submitted That Met QC Criteria: February 17, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): February 9, 2018
• Last Update Submitted That Met QC Criteria: February 8, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting
• Other Study ID Numbers: 2014CB543201-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No